IDV Associated Nephrotoxicity Clinical Trial
Official title:
Efficacy and Safety of a Saquinavir Based Regimen in HIV-1 Infected Thai Patients Who Have Chronic IDV Associated Nephrotoxicity.
Efficacy and safety of a saquinavir (SQV) based regimen in HIV-1 infected Thai patients who have chronic indinavir (IDV) associated nephrotoxicity.
Primary objective:
To determine whether a switch to a SQV can cause improvements in renal function in patients
with chronic IDV associated nephrotoxicity without improvement after IDV dose reduction.
Secondary objective:
1. To describe the pathophysiology of chronic IDV associated renal impairment through
renal biopsies at baseline and week 48
2. To describe the pathophysiology of chronic IDV associated renal impairment through
renal tubular function at baseline and week 48
3. To determine whether a switch to an SQV can cause improvements in renal pathophysiology
in patients with chronic IDV associated nephrotoxicity through renal biopsies performed
at baseline and at weeks 48
4. To determine whether a switch to an SQV results in improvements in hypertension, lipid
profiles and cutaneous side effects
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment